Risk of incremental toxicities and associated costs of new anticancer drugs: A meta-analysis

Abstract

Purpose: There are increasing reports of rare but serious toxicities caused by new anticancer drugs, and there are costs associated with their management. Methods: We identified anticancer drugs approved by the US Food and Drug Administration from 2000 to 2011 and pivotal trials supporting their registration. Twelve frequent grade 3 to 4 adverse event (AEs) were weighted and pooled in a meta-analysis. Estimates of incremental drug prices and ncremental costs for management of AEs were calculated according to type of new agent based on target specificity. Results: We identified 41 studies comprising 27, 539 patients and evaluating 19 experimental drugs. Agents directed against a specific molecular target on cancer cells had a lower incidence of grade 3 to 4 toxicities compared with controls (median risk ratio [RR], 0. 67; P =. 22), whereas less-specific targeted agents, including angiogenesis inhibitors (median RR, 3. 39; P < 001). Median incremental drug price for experimental agents was $6, 000 per patient per month Median cost of managing toxicity was low compared with drug costs but higher than controls for treatment with less-specific targeted agents and chemotherapies. Conclusion: Newly approved anticancer drugs are associated with increased toxicity, except for agents with a specific molecular target on cancer cells. Management of toxicity leads to a small increase in overall cost of treatment. Frequency of toxicity and associated costs are likely higher in less-selected patients treated in general oncologic practice. Development of biomarker-driven agents should be encouraged.